(108 days)
Not Found
No
The document describes "real-time digital analysis of optical signatures" and "DSP electronics" which are standard digital signal processing techniques, not necessarily AI/ML. There is no mention of AI, ML, deep learning, training data, or any other terms typically associated with AI/ML in the provided text. The performance studies focus on comparison to predicate devices using traditional metrics like detecting blood flow and pulse pressure, not AI/ML performance metrics.
No.
The "Intended Use / Indications for Use" states the device is "intended for studies of blood flow in the microcirculation" and allows clinical investigators to "look deeper into the body, delivering images of blood flow under the skin's surface without ever touching the patient." This describes an imaging or diagnostic device, not one that treats or heals.
Yes
Explanation: The device is intended for "studies of blood flow in the microcirculation" and "delivering images of blood flow under the skin's surface," which are used by "clinical investigators" and "healthcare providers" to gain information about a patient's physiological state. This information is crucial for understanding the patient's condition, which aligns with the definition of a diagnostic device. While it doesn't state it provides a definitive diagnosis, the information it provides supports diagnostic processes.
No
The device description explicitly lists multiple hardware components including a mobile cart, laptop computer, LCD screen, mechanical arm, CMOS camera, and disposable LED cartridges.
Based on the provided information, the Spectral MD DeepView system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- DeepView's Function: The DeepView system is described as a non-invasive device that uses optical signatures and infrared light to detect blood flow under the skin's surface without touching the patient. It provides images of blood flow directly from the patient's body.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens taken from the patient.
Therefore, the DeepView system falls under the category of an in vivo diagnostic or imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, neurosurgery and anesthetics.
Product codes (comma separated list FDA assigned to the subject device)
DPT
Device Description
Deep View system-based technology combines real-time digital analysis of optical signatures, thereby sensitizing an imager to photon-tissue interactions deep below the skin's surface. These image signatures are unique to the body and relate directly to a person's dynamic nature - both in terms of the quantity and quality of important physiological properties. This technology is non-invasive and uses no harmful radiation such as X-rays and allows clinical investigators to look deeper into the body, delivering images of blood flow under the skin's surface without ever touching the patient.
The DeepView system is composed of a mobile cart with uninterruptible power supply, a laptop computer with remote multimedia keyboard, an LCD screen mounted on a bracket that allows for side-to-side panning, a mechanical arm, a CMOS camera with DSP electronics, and disposable LED cartridges with an associated LED driver control board.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical signatures, infrared light, Photoplethysmography (PPG)
Anatomical Site
human tissue (deep below the skin's surface)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical investigators, healthcare providers, healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Comparison testing was performed with both the moorLDI and Avant 9600 predicates. Comparison testing was conducted to demonstrate that the DeepView can, using optical methods, detect blood flow and pulse pressure. Using these attributes, DeepView was tested alongside the predicate devices to show substantial equivalence in detecting pulse frequency and in producing flow images. Comparison testing included camera distance testing and tissue phantom testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The comparison testing conducted demonstrates that the DeepView is substantially equivalent to the predicate devices identified and does not introduce any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K980383 Moor Instruments - moorLDI Laser Doppler Imager, K032841 Moor Instruments - moorLDI2-IR Infrared Laser Doppler Imager, K023044 Nonin - Avant Model 9600 Pulse Oximeter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).
0
※Spectral MD™
5. 510(k) SUMMARY
K124049
APR 1 8 2013
| Submitter: | Spectral MD TM, Inc.
5959 Harry Hines Blvd.
Professional Office Building 1, Suite 426
Dallas, Texas 75235 | APR 18 20 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Contact Person: | Mr. Kenneth L. Block
VP Quality and Regulatory Affairs
TEL: 972-499-4934
FAX: 972-767-4325
block@spectralmd.com | |
| Date Prepared: | December 28, 2012 revised March 25, 2013 | |
| Trade Name: | DeepView Digital Video Physiological Portable Imaging System | |
| Common Name: | Extravascular Blood Flow Probe | |
| Classification Name: | DPT 870.2120 Probe, Blood Flow, Extravascular
DQA 870.2700 Oximeter | |
| Predicate Device: | K980383 Moor Instruments - moorLDI Laser Doppler Imager
K032841 Moor Instruments - moorLDI2-IR Infrared Laser Doppler Imager
K023044 Nonin - Avant Model 9600 Pulse Oximeter | |
| Device Description: | Deep View system-based technology combines real-time digital analysis of optical
signatures, thereby sensitizing an imager to photon-tissue interactions deep below
the skin's surface. These image signatures are unique to the body and relate directly
to a person's dynamic nature - both in terms of the quantity and quality of important
physiological properties. This technology is non-invasive and uses no harmful
radiation such as X-rays and allows clinical investigators to look deeper into the
body, delivering images of blood flow under the skin's surface without ever
touching the patient.
The DeepView system is composed of a mobile cart with uninterruptible power
supply, a laptop computer with remote multimedia keyboard, an LCD screen
mounted on a bracket that allows for side-to-side panning, a mechanical arm, a
CMOS camera with DSP electronics, and disposable LED cartridges with an
associated LED driver control board. | |
| Statement of
Intended Use: | The Spectral MD DeepView system is intended for studies of blood flow in the
microcirculation. The DeepView system is suitable for a wide variety of clinical
applications including plastic surgery, diabetes, dermatology, vascular surgery,
wound healing, neurology, physiology, neurosurgery and anesthetics. | |
: ・
1
≥Spectral MD"
Summary of Technological Characteristics:
The DeepView uses infrared light to detect pulsatile blood flow in patients, and then provides 2D color images of relative perfusion distribution to healthcare providers. The technology used is non contact Photoplethysmography (PPG). PPG allows the DeepView to take advantage of the deep penetration of near IR light in human tissue.
The DeepView, as well as all three predicate devices, is portable and use software to control the device operations, collect the patient data, analyze the data, present the data to the user, etc. The DeepView displays 2D color images demonstrating relative blood flow, similar to the moorLDI and moorLD12-1R predicate devices. The new device and the three predicate devices can all store patient data, which can then be examined later by healthcare professionals.
The DeepView and the moorLDI and moorLDI2-IR are non-contact regarding patient interaction. All devices (new and predicate) require light and optics for detection of blood flow. The two predicate imaging devices (moorLDI and moorLD12-1R) use laser illumination, while the DeepView device and predicate Avant 9600 device use LED illumination.
Summary of Test Data:
Direct comparison testing was performed with both the moorLDI and Avant 9600 predicates. Comparison testing was conducted to demonstrate that the DeepView can, using optical methods, detect blood flow and pulse pressure. Using these attributes, DeepView was tested alongside the predicate devices to show substantial equivalence in detecting pulse frequency and in producing flow images. Comparison testing included camera distance testing and tissue phantom testing.
The comparison testing conducted demonstrates that the DeepView is substantially equivalent to the predicate devices identified and does not introduce any new issues of safety and efficacy.
Conclusion:
Spectral MD™, Inc. considers the DeepView to be substantially equivalent to the predicate devices listed above This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 18, 2013
Spectral MD™, Inc. % Ken Block Consulting Ms. Diane Rutherford, BSME, MSMSE 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K124049
Trade/Device Name: DeepView Digital Video Physiological Portable Imaging System Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood flow probe Regulatory Class: Class II Product Code: DPT Dated: March 25, 2013 Received: March 28, 2013
Dear Ms. Rutherford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Diane Rutherford, BSME, MSMSE
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
PeterDi Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number: K124049
Device Name: DeepView
Indications for Use:
The Spectral MD DeepView system is intended for studies of blood flow in the microcirculation. The DeepView system is suitable for a wide variety of clinical applications including plastic surgery, diabetes, dermatology, vascular surgery, wound healing, neurology, neurosurgery and anesthetics.
| Prescription Use | X | AND/OR | Over-the-Counter Use |
|---|---|---|---|
| (21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
| Neil R Ogden | |
|---|---|
| 2013.04.16 15:13:45 -04'00' | |
| (Division Sign-Off) for MXM | |
| Division of Surgical Devices | |
| 510(k) Number | K124049 |